FDA announces it will consider creating a class of over-the-counter hearing aids and will remove certain requirements in order to make the devices easier to access.

Marie Thibault

FDA cuts straight to the heart of the hearing aid debate, announcing that it will consider creating a category of over-the-counter hearing aids. In addition, the agency said the current rule requiring patient to undergo a medical evaluation or sign a waiver before buying a hearing aid will not be enforced.

Phenotyping, describing the patient on a clinical level, has emerged as a necessary step in helping clinicians diagnose rare and ultra-rare genetic diseases.

Dekel Gelbman

Diagnosing rare and ultra-rare genetic diseases can be extremely difficult for geneticists. The diagnostic odyssey, from the primary point of care, through the specialty clinics and to the molecular testing labs, can take up to 7.6 years to come to an appropriate diagnosis. According to recent survey results, patients living with rare diseases visit an average of 7.3 physicians before receiving an accurate diagnosis. This process can be compared to solving a mystery, with the geneticist...

Hummingbird Med Devices

Recall reason: According to information on the FDA recall page, "the Y-shaped connector and the yellow tube may disconnect from each other prior to or during use. This could lead to blood or fluid leakage."

When recall was initiated: October 1, 2015, recall listed in FDA database on May 26, 2016

Arrow International

Recall reason: According to information on the FDA recall page, "the sheath body may separate from the sheath hub during the insertion procedure. This may cause significant bleeding . . . and an interruption of the inflating-deflating balloon therapy."

Boston Scientific

Recall reason: According to information on the FDA recall page, "the catheter shaft may break at various points along the device . . . If breakage occurs while the device is in a patient, pieces of the catheter may block blood supply to the heart or blood vessels. This could result in the need for additional medical procedures, patient injury, or death."

HeartWare

Device: Batteries used for the HeartWare Ventricular Assist Device (HVAD) with serial numbers BAT000001 to BAT 199999, model number 1650.

Recall reason: According to information on the FDA recall page, "the batteries . . . may lose power prematerly due to faulty cells." If another power source is not connected, "the pump will stop working and the patient may experience serious adverse health consequences, including death."

Alere

Device: Alere planned to take the INRatio and INRatio2 PT/INR Monitoring System, including INRatio Test Strips, off the market and to stop manufacturing the product.

Recall reason: According to information on the FDA recall page, "the INRatio System may generate an incorrect low result . . . If an incorrect low INR result is acted upon . . . the patient may be at risk of major or fatal bleeding."

Baxter

Recall reason: According to information on the FDA recall page, the agency received "reports about the presence of particulate matter and the potential absence of filter membrane layers int eh filter set . . . [this] may contaminate a solution. This could result in bloodstream infections that may cause fever, septic shock, multiple organ dysfunction, and other serious adverse health consequences including death."

St. Jude Medical

Recall reason: According to information on the FDA recall page, there were "reports of rapid battery failure caused by deposits of lithium . . . forming within the battery, and causing a short circuit. If the battery unexpectedly runs out before the patient is aware of the rapid...